The National Institute of General Medical Sciences (NIGMS)
invites applications for Institutional Development Award (IDeA) Networks of
Biomedical Research Excellence (INBRE) awards from investigators at
biomedical research institutions that award doctoral degrees in the health
sciences or sciences related to health or at independent biomedical research
institutes with ongoing biomedical research programs funded by the NIH or
other Federal agencies within the IDeA eligible states. The purpose of the INBRE
program is to augment and strengthen the biomedical research capacity of an
IDeA-eligible state. The INBRE program represents a collaborative effort to
sponsor research between research intensive institutions and institutes,
primarily undergraduate institutions, community colleges, and Tribally Controlled
Colleges and Universities (TCCUs), as appropriate.

Applicants should have an established state-wide network
before submission. Since only one award will be made per IDeA-eligible state,
only one application should be submitted per state.

The primary goals of the INBRE program are to: 1) build on
the established multi-disciplinary research network with a scientific focus
to strengthen the biomedical research expertise and infrastructure of the
lead and partner institutions; 2) build and increase the research base and
capacity by providing support to faculty, postdoctoral fellows and graduate
students at the participating institutions; 3) provide research opportunities
for students from primarily undergraduate institutions, community colleges
and TCCUs as appropriate and serve as a "pipeline" for these
students to continue in health research careers within IDeA states; and 4)
enhance science and technology knowledge of the state's workforce.

Key Dates

Posted Date

February 9, 2017

Open Date (Earliest Submission Date)

March 14, 2017

Letter of Intent Due Date(s)

March 14, 2017

Application Due Date(s)

Any due dates on or after Jan 25, 2018 must use reissued FOA.

April 14, 2017; March 27, 2018; March 27, 2019, by 5:00 PM
local time of applicant organization. All types
of applications allowed for this funding opportunity announcement are due
on these dates.

Applicants are encouraged to apply early to allow adequate
time to make any corrections to errors found in the application during the
submission process by the due date.

AIDS Application Due Date(s)

Not Applicable

Scientific Merit Review

October 2017; October 2018; October 2019

Advisory Council Review

January 2018; January 2019; January 2020

Earliest Start Date

April 2018; April 2019; April 2020

Expiration Date

New Date January 24, 2018 per reissuance of FOA (Original Expiration Date: March 28, 2019)

Due Dates for E.O. 12372

Not Applicable

** ELECTRONIC APPLICATION SUBMISSION REQUIRED**

NIH’s new Application Submission System & Interface for
Submission Tracking (ASSIST) is available for the electronic preparation and
submission of multi-project applications through Grants.gov to NIH. Applications
to this FOA must be submitted electronically using ASSIST or an institutional
system-to-system solution; paper applications will not be accepted. ASSIST
replaces the Grants.gov downloadable forms currently used with most NIH
opportunities and provides many features to enable electronic multi-project
application submission and improve data quality, including: pre-population of
organization and PD/PI data, pre-submission validation of many agency business
rules and the generation of data summaries in the application image used for
review.

Required
Application Instructions

It is critical that applicants follow the Multi-Project (M)
Instructions in the SF424
(R&R) Application Guide, except where instructed to do otherwise (in
this FOA or in a Notice from the NIH Guide for Grants and Contracts)
and where instructions in the Application Guide are directly related to the
Grants.gov downloadable forms currently used with most NIH opportunities.
Conformance to all requirements (both in the Application Guide and the FOA)
is required and strictly enforced. Applicants must read and follow all
application instructions in the Application Guide as well as any
program-specific instructions noted in Section
IV. When the program-specific instructions deviate from those in the
Application Guide, follow the program-specific instructions. Applications that
do not comply with these instructions may be delayed or not accepted for review.

The National Institute of General Medical Sciences (NIGMS)
of the National Institutes of Health (NIH) invites applications for
Institutional Development Award (IDeA) Networks of Biomedical Research
Excellence (INBRE) grants to independent biomedical research institutes and/or
biomedical research institutions that award doctoral degrees in the health
sciences or sciences related to health within IDeA-eligible states. INBRE
applications represent collaboration between research intensive universities
and other research intensive institutions and institutes, primarily
undergraduate institutions, community colleges and Tribally Controlled Colleges
and Universities (TCCUs), as appropriate.

This Funding Opportunity Announcement (FOA) is to provide an
opportunity to build on the successes of the INBRE program to augment and
strengthen the state's biomedical research capacity. The primary goals of the
INBRE program are to: 1) build on the established multi-disciplinary research
network with a scientific focus to strengthen the lead and partner institutions'
biomedical research expertise and infrastructure; 2) build and increase the
research base and capacity by providing support to faculty, postdoctoral
fellows and graduate students at the participating institutions; 3) provide
research opportunities for students from primarily undergraduate institutions,
community colleges and minority serving institutions and serve as a
"pipeline" for these students to continue in health research careers
within IDeA states; and 4) enhance science and technology knowledge of the
state's workforce.

For the purposes of this FOA, “primarily undergraduate
institutions” include U.S. two-year, four-year, masters-level, and small
doctoral colleges and universities that (1) grant baccalaureate degrees in
NIH-supported fields, or provide programs of instruction for students pursuing
such degrees with institutional transfers (e.g., two-year schools); (2) have
undergraduate enrollment exceeding graduate enrollment; and (3) award an
average of no more than 10 Ph.D. or D.Sc. degrees per year in biomedical and
behavioral sciences.

The INBRE program seeks to promote the development and
expansion of unique, innovative, state-of-the-art biomedical and behavioral
research at institutions in IDeA-eligible states, encompassing the full spectrum
of basic, clinical and translational sciences. The NIH recognizes that the
contributions from the institutions in IDeA-eligible states are important and
essential in fulfilling the promise of the NIH research agenda. The intent of
this FOA is to continue assisting these institutions to implement and use the
technologies and other resources needed to conduct state-of-the-art biomedical
and behavioral research and provide research experiences to students at
baccalaureate institutions, community colleges and TCCUs.

Background

The IDeA Program was authorized by Congress for broadening
the geographic distribution of NIH funding for biomedical and behavioral
research by enhancing the competitiveness for research funding of institutions
located in states that historically have not received significant levels of
research funding from NIH.Disparate funding
distributions may stem in part from having relatively few competitively
supported biomedical and behavioral investigators in IDeA states. Statewide
IDeA Networks of Biomedical Research Excellence supported through this FOA are
intended to develop the research resources and modern laboratories needed to
attract established investigators, and to develop and enhance the research
skills of talented investigators and promising students within each state.

The INBRE program began in 2001 by providing planning grants
for three years. These programs were competed in 2004, 2008 and 2012 to
establish inclusive statewide multidisciplinary research networks with
scientific foci to promote the development, coordination, and sharing of
research resources and expertise that will expand the research opportunities
and increase the number of competitive investigators in the IDeA-eligible
states. INBREs also were intended to enhance the caliber of scientific faculty
at research institutions and primarily undergraduate schools, thereby
attracting more promising students to these organizations. The purpose of this
FOA is to build on the successes of the existing INBREs to augment and strengthen
biomedical research capacity within IDeA states. Each INBRE is a statewide
network to be composed of doctoral degree-granting institution(s) or research
institute(s) with one organization serving as the lead institution, and to
include primarily undergraduate institutions, community colleges and TCCUs as
partner institutions appropriate to the state. The inclusion of investigators
and institutions in the network that serves the under-represented minorities in
biomedical and behavioral research within the INBRE is strongly encouraged.

Program
Description and Requirements

The purpose of INBRE program is to:

enhance the research capacity of institutions through
collaborative partnerships, develop areas of potential research, enhance staff
development, and provide access to research resources, so they can participate
more fully in the competition for NIH awards; and

provide hands-on research experiences and career enhancement activities
for participating students at primarily undergraduate institutions, community
colleges, and TCCUs and serve as a pipeline to health research careers.

The FOA is intended to strengthen the basic science
departments of primarily undergraduate institutions, community colleges and
TCCUs. This Program provides opportunities for primarily undergraduate
institutions, community colleges, and TCCUs to support and retain current
productive faculty and recruit outstanding faculty who conduct research in the
specific proposed thematic areas which can attract promising students to
health-related science through both didactic education and research
experiences. These institutions may develop new courses or improve existing
ones to augment the science curriculum, and to stimulate and strengthen the
role of research into curricula traditionally limited to classroom instruction.

Students who are well trained in science and technology can
enhance the quality of the scientific workforce available to participate in NIH
funded research. With better employment opportunities, more students may
choose to stay within the state. The primarily undergraduate institutions also
serve as an important pipeline to the science departments of graduate schools
within IDeA states for students to pursue graduate education. With access to
promising, biomedically-trained students, the graduate schools in the IDeA
states can more readily build a critical mass of investigators to conduct
biomedical research by recruiting competitive investigators from other
institutions as well as recruiting some of their own graduates. This aligns
well with the NIH mission to diversify the workforce to lead recruitment of the
most talented researchers from all groups; improve the quality of the
educational and research environment; balance and broaden the perspective in
setting research priorities; improve the ability to recruit subjects from
diverse backgrounds into clinical research protocols; and improve the Nation's
capacity to address and eliminate health disparities.

The application must include a scientific focus in one or
more thematic areas, such as neuroscience, cancer, genomics, proteomics,
developmental biology and genetics, toxicology or any of the biomedical and
behavioral scientific areas relevant to the mission of NIH, and may include
basic, clinical, and/or translational research approaches to attain the goals
of the proposed network. The broad thematic areas will encourage and facilitate
interactions and cross-collaborations among INBRE, Center of Biomedical
Research Excellence (COBRE), IDeA Clinical and Translational Research Center
(IDeA-CTR) and other NIH supported programs. This will also promote data and
resource sharing within the statewide network and the region. It is also
anticipated that, in some instances, support through this FOA will facilitate
the development of new disease-specific research programs or augment the
capability of existing programs.

Scientific leadership provided by one or more established
biomedical research faculty is critical to the success of the INBRE initiative,
especially for the career enhancement of promising investigators, postdoctoral
fellows, and students. Some applicant institutions may have faculty who hold
significant peer-reviewed funding from either Federal or non-Federal sources to
conduct research. Those faculty may be included as advisors, collaborators, and
scientific members of a multidisciplinary steering committee. The network is
intended to support investigators from several complementary disciplines at the
grantee and partner graduate and primarily undergraduate institutions,
community colleges and TCCUs. The focus of the planned research network will
determine the need for core research facilities and modern instrumentation.
Faculty at participating institutions will receive support to establish or
enhance existing research laboratories, acquire specialized equipment, and hire
postdoctoral fellows, students and technical assistants.

The NIH is committed to working toward elimination of health
disparities among racial and ethnic populations. Investigators proposing
research that involves human subjects are strongly encouraged to include
representation from the unique and diverse populations within the IDeA states
for valid analyses of factors that may influence health disparities. INBREs are
encouraged to interface and collaborate with other appropriate programs that
address health disparities and health issues in underserved communities.

Under this FOA, INBREs are strongly encouraged to
collaborate and interface with pre-kindergarten to grade 12 (P-12)/pre-college
level programs such as Science
Education Partnership Award (SEPA), for developing a continuous pipeline of
students to provide for the INBRE program to train future generation of a
diverse biomedical research workforce.

INBRE
Network Characteristics

Since only one award will be made per IDeA-eligible state,
only one application should be submitted per state.

The statewide network is to be composed of baccalaureate,
master's level degree-granting institutions, non-profit research institutes,
community colleges, and/or TCCUs that will provide the sites for the conduct of
thematic, multidisciplinary, biomedical and behavioral research. An INBRE
scientific network must include a doctoral degree-granting institution or
research institute as the applicant institution in the eligible IDeA states and
ideally six to eight baccalaureate, master's level degree-granting institutions
and community colleges or TCCUs participating in the thematic research
activity. One or two additional biomedical research-intensive institutions may
participate in the network and share in the portion of the budget dedicated to
the lead institution. New undergraduate institutions that have not been a part
of the network previously but contribute to the thematic research effort may be
included, if appropriate, in the proposed scientific network. The states that
elect to do so or states that do not have appropriate eligible undergraduate/graduate
institutions with focus on the scientific area relevant to the thematic focus
proposed in the application may include partner institutions from other IDeA
states. In that case, the IDeA funds may be transferred to the partner
institution in another IDeA state via subcontract. The inclusion of
institutions representing faculty and students underrepresented in biomedical
and behavioral sciences in the INBRE is encouraged. This is an effective means
of developing a diverse scientific and academic workforce.

The six to eight baccalaureate, master's level
degree-granting institutions, community colleges or TCCUs that participate in
the thematic multidisciplinary research activity can serve as a pipeline for
future independent biomedical investigators. Undergraduate institutions that
are a component of a university that includes a graduate school that confers
doctoral degrees in one or more sciences, but are not research intensive or do
not conduct biomedical research as a principal activity, are eligible to
participate as a network partner institution. Faculty at the undergraduate
colleges of research-intensive institutions who do not have appointments in the
graduate school may receive research support via this initiative. Further, new
primarily undergraduate institutions and community colleges or TCCUs that have
not been a part of the original network but could contribute to the proposed
thematic research and/or efforts to address the health needs of the community
may be included in the scientific network.

It is the responsibility of INBRE leadership to define an
effective statewide partnership and collaboration. The network is to include
undergraduate and graduate students and postdoctoral fellows, undergraduate and
graduate science department faculty, and faculty and students from community
colleges and TCCUs. Special efforts must be undertaken to enhance the
recruitment and career development of participating students, fellows and
faculty. This FOA strongly encourages forging interactions and cross-collaborations
among INBRE, COBRE and IDeA-CTR programs to enhance communication among
programs, leverage resources where appropriate, and provide students a broad
continuum of research opportunities.

INBRE
Components

Administrative
Core

The Administrative Core will provide the logistical support
for the network and to the External Advisory Committee. The Administrative Core
Lead (Program Director/Principal Investigator (PD/PI)) is responsible for
management, staffing and resource allocation, and for administering the award
in accordance with NIH policies. The Administrative Core Lead will serve as
Chairperson of the INBRE Steering Committee and in consultation with this
committee select the core directors. The Administrative Core will also develop
programs to meet the career building and enhancement needs of the research faculty,
fellows, and graduate and undergraduate students, and students from community colleges
and TCCUs. For example, activities may be designed for students, fellows and
faculty to hone their investigative skills. Support also may be provided for
attending national scientific meetings and workshops to interact with the
scientific leaders in the field and learn about the most current research
advances in the field.

The Administrative Core will serve to oversee ongoing
research activities, any clinical studies, analysis of research results, other
funding sources, and other information relevant to the thematic scientific
focus that is being investigated within the Network. Additionally, regional
scientific grantsmanship and scientific presentation workshops, seminar and
lecture series, and visiting faculty programs can be organized as a part of the
Administrative Core's scope of career enhancement activities.

The Administrative Core may include a number of
role-modeling and related career activities for four-year primarily
undergraduate institutions, community colleges, and TCCUs. INBRE programs are
encouraged to develop career activities designed to increase the number and
quality of graduate program applications submitted by students. Activities to
these institutions through mechanisms such as (but not limited to) seminars,
lectures, workshops or short courses are encouraged. Activities could also
include sponsorship of graduate school workshops and networking activities, improve
communication skills, career counseling, and laboratory/research experiences at
network research laboratories or field sites (e.g., community sites).

INBREs are encouraged to develop activities that focus on
enhancing the quality of instruction and providing research experiences
relevant to students and their communities from the partner institutions. This
may include activities that focus on incorporating new courses in science
curricula, and involving their students in research projects that are linked to
reducing health disparities and developing interventions to improve the health
status of their communities.

As communication among investigators within the research
network is essential, the Administrative Core may provide electronic networking
to inform investigators both within and outside the network of the availability
of and access to modern technologies at research core facilities both within
the network and located at other NIH-supported sites around the country.

Required Committees under Administrative Core

Steering
Committee: The Program Director/Principal Investigator (PD/PI) will
serve as Chairperson of the Steering Committee (SC). The PD/PI, Program Coordinator
(PC) and representatives from network partner institutions must agree to
participate as members of the INBRE SC. The SC will consist of no more than 20
members and will include up to two members from each network partner
institution, one is a senior administrative person, the other one can be someone
with scientific expertise and background. The Vice President for Research of
the awardee institution, or their surrogate, must participate as a member of
the SC. The members of the SC will establish the policies and operating
procedures of both the Steering Committee and the INBRE. The SC will meet at
least three times during the first year of the award and at least semi-annually
thereafter. The SC will develop strategies as to how it will interact with the
External Advisory Committee, the other mandatory committee described below. The
Administrative Core will provide logistical support to the SC. The PC, in
conjunction with SC, will provide management oversight for the development of
an Evaluation Plan to determine the impact of the INBRE program. The PD/PI in
consultation with this committee will select the core directors. Collaborations
with investigators from outside an IDeA state are permissible, but must be
agreed upon by the INBRE Steering Committee.

The members of the SC will regularly review the progress of
faculty investigators and their career plans in terms of their research
projects and providing research experiences to the students. This oversight and
input are in addition to that provided by the EAC and may not act as a
substitute for the EAC.

External
Advisory Committee: Each INBRE must include an External Advisory
Committee (EAC). The SC should establish rules governing the composition of the
EAC and the tenure of the Chairperson. The composition of the EAC is to include
at least three to five members with appropriate scientific expertise in the
thematic focus area(s), who can provide advice to the SC for scientific,
administrative, and other matters. The EAC must meet at least twice per year.
The EAC critiques the scientific progress of the INBRE and also offers advice
on scientific matters to the INBRE PD/PI. The EAC activities include developing
and planning concepts and programs, encouraging and assisting faculty
development and enhancement, identifying resources, evaluating the development
of the network, and evaluating progress of the individual pilot projects as
well as the overall INBRE program. The PD/PI will share the advice and
critiques provided by the EAC with other INBRE investigators and the Steering
Committee of the network. The EAC also will review and recommend candidate
investigators for replacement/substitute projects, as required, before such
requests are forwarded to the NIGMS for programmatic review. Video-,
teleconferencing or other means may be used in situations where it would be
difficult to hold an in-person meeting. A summary of the issues discussed at
each EAC meeting, recommendations made, and actions taken must be included in
the yearly progress reports submitted to the NIGMS.

Evaluation
Plan and Milestones: The Administrative Core is responsible for
overseeing an evaluation plan for monitoring and documenting progress towards
achieving target goals and timelines. The evaluation should assess whether the
effectiveness of the approach taken will meet the goals or benchmarks for
building an effective institutional and statewide scientific network.

As a part of the evaluation process, students who are
receiving biomedical research experiences and career enhancement activities should
be tracked, and their outcomes should be reported to the NIH in the annual
progress report (for example, the total number of students who had research
experiences, have gone to graduate and professional schools, or have entered
the biomedical workforce).

One of the objectives of INBRE is to provide undergraduate
faculty and students research support and serve as a pipeline for undergraduate
students to continue in health research careers. The mission of most primarily
undergraduate institutions and liberal arts colleges is teaching and in some
cases teaching and research to provide students experiences and exposure to
research. The intent of INBRE is not to transform liberal arts primarily
undergraduate institutions into biomedical research centers but rather to
augment the science curriculum. Obtaining R01 support by investigators at these
institutions is not expected and is not a criterion for evaluation. However,
these investigators may seek and obtain research support via mechanisms such as
Academic Research Enhancement Award (AREA) and NIMHD Building Research
Infrastructure and Capacity (BRIC) (previously known as the NIMHD Research
Infrastructure in Minority Institutions (RIMI) program) grants. However, at the
lead institutions, investigators may apply for and obtain R01 and Program
Project grant support, and in some cases faculty at the primarily undergraduate
institutions (PUIs) may participate as investigators in these Program Project
grants.

The success of researchers from the network partner
institutions may be measured by attainable metrics that are appropriate to the
missions of their institutions. Criteria for evaluating the progress of these
researchers may include evidence of scholarly activities including
publications, offering of new courses and programs, providing research
experiences to students, impact on the community, attending and presenting
research findings at scientific meetings and conferences, submission of
external grant applications to NIH and other Federal and non-Federal agencies,
and acquisition of awards such as AREA (R15), exploratory/pilot project grants
(R03 and R21), career development awards (K01 and K08) or other Federal or
non-Federal Agency awards.

Bioinformatics
Core

The Bioinformatics Core will provide resources in research, career
enhancement, and education. For research, the Core will provide investigators
access to the technical expertise and data management and analysis tools
required for competitive, multidisciplinary biomedical research. Careful
consideration must be given to optimizing access to bioinformatics and other
related tools for investigators in the network. This core will have a
substantial impact on enabling the pursuit of research areas by the faculty and
students participating in the network. This core may promote informatics career
enhancement and education, and development of Bioinformatics curriculum and
degree programs as well as understanding of approaches and methods for data
management, develop methods for multi-center research and resource sharing, and
provide methods for secure and confidential data sharing.

Access to and utilization of bioinformatics tools and
resources rely on a comprehensive supporting infrastructure (often termed
cyberinfrastructure) that integrates data-gathering facilities, computing
hardware, data analysis and informatics tools, software and middleware,
high-bandwidth network connectivity, and technical support. Robust network
connectivity facilitates research collaboration and sharing of resources across
geographical boundaries and provides access to rural areas and other
hard-to-reach populations. Enhanced network connectivity also broadens access
to education and career enhancement programs that further national efforts to
strengthen the biomedical research workforce. Under this Core, applicants may
develop plans to enhance network connectivity and high-end computational power
within their state. Applicants within a common geographical region may also
develop a multi-state plan to collectively address research cyberinfrastructure
needs and gaps. Such efforts should seek to leverage funds from other federal,
state, and local sources to the greatest extent possible. The Bioinformatics
Core may also provide resources to enhance communications within the state and
with the rest of the world, including, but not limited to, library access to
research journals and video-teleconferencing services, and the development of
telemedicine networks.

Research
Cores

Applicants may include cores, such as centralized research
facility and instrumentation cores. Sharing research resources among INBRE and
COBRE investigators is strongly encouraged. As much as practicable, applicants
should seek to utilize existing equipment and instrumentation supported by
other COBRE or INBRE awards.

It is expected that proposed core should be unique and not
duplicate services or facilities that already exist at the applicant
institution. Utilization/modification/expansion of existing resources to
accomplish the goals of proposed research is strongly encouraged. Proposed
research cores that appear to replicate services already available at the
applicant institution will not be allowed without extensive justification.

Institutions may also include a Community-Based
Participatory Research (CBPR) Core, to facilitate the conduct of new pilot
projects or to expand ongoing projects in community-based research, with an
emphasis on those diseases that disproportionately affect racial and ethnic
minorities and rural and other medically underserved populations. A
community-based participatory collaborative approach involves partners,
community residents and scientists in the research process and recognizes the
unique strengths that each brings to research. The CBPR Core can help develop
critical infrastructure in medically underserved communities to increase their
involvement in clinical and translational research and advise investigators in
the conduct of this research modality.

Developmental
Research Project Program

Each INBRE program must have a Developmental Research
Project Program with an internal mechanism (internal Funding Opportunity
Announcement) for obtaining and awarding multidisciplinary developmental
research projects to investigators at the partner institutions. The projects,
including research projects or pilot projects, should be collaborative and
stand-alone, but share common scientific themes. The projects should focus on
the broad, multidisciplinary research theme(s) of the network and include
projects from both the research-intensive institutions as well as primarily undergraduate
and other institutions involved in the INBRE. Projects selected should reflect
the structure and breadth of the INBRE Network with the focus on the
infrastructure to provide research opportunities to students.

Each faculty investigator of a developmental project should
be assigned at least one science advisor. The advisors should have research
expertise relevant to the scientific area(s) to be developed within the INBRE.
The science advisor may be a collaborator on the faculty investigator's research
project. They will help oversee the proposed research and career enhancement of
promising investigators. The science advisor is an established faculty member
experienced in obtaining external support and maintaining an independent
research laboratory. In some instances a suitable advisor may not be available
within the investigator's institution; therefore it is acceptable to enlist
appropriate individual from outside institutions.

In some cases, COBRE investigators, where appropriate, may
serve as science advisors to INBRE investigators and/or students. Attaining R01
support is not a criterion for evaluation of pilot project investigators
located at primarily undergraduate institutions. Some research support may be
attained by investigators at primarily undergraduate institutions, community
colleges or TCCUs, i.e., Academic Research Enhancement Award (AREA/R15) grants,
R03s, even R01s but that is not a requirement of this program.

A single investigator at the awardee or network institutions
should supervise each research project. Each investigator is responsible for
ensuring that the project's specific aims are met. The research excellence of
these projects will be enhanced by effectively using the scientific and
technical strengths of collaborating investigators and/or science advisors.
Promising investigators who are resident at institutions in IDeA states but are
not a part of the scientific network of the INBRE may receive research support
through an adjunct appointment at one of the partner institutions or as
collaborators on research projects.

The award of a Research Project Grant or a major grant award
to a faculty investigator from the lead or primarily undergraduate institutions
should be viewed as a milestone and a criterion for changing the status of an
investigator supported by the INBRE to independent investigator. Investigators
who have acquired independent status or completed a research project should not
be excluded from Network activities. These investigators should be allowed access
to core facilities and should be encouraged to participate in collaborative
research efforts. If appropriate, an investigator who has acquired independent
research support may direct a core facility or serve as a science advisor to
other investigators and students. INBRE support cannot be provided in instances
where an investigator receives a new award and that award overlaps or is
significantly similar to that described in the INBRE application. However, if
the specific aims of the investigator's grant application are significantly
different from the project described in the INBRE, then the investigator should
complete his/her INBRE project and provide research experiences to the
students. In this latter case, continued support for personnel (e.g., postdoctoral
fellows, graduate and undergraduate students, technicians, etc.) associated
with the INBRE project can be provided.

An investigator who leaves the Network may be replaced by a
new investigator. Replacement investigators and new research projects may be
substituted following review by the PD/PI and the EAC. The PD/PI must
communicate the EAC's recommendation along with the research project to the
NIGMS for programmatic and administrative review.

In some instances, an investigator may be placed on
probation or considered for removal from the INBRE program if a review by the
EAC indicates a failure by the investigator to make significant progress toward
achieving the specific aims of his/her project and/or achieving the goals and
objectives of the INBRE program to provide research experiences to students.

Alteration
and Renovation

Alteration and Renovation (A&R) costs to improve
existing core laboratories, research laboratories and/or animal facilities at
the primarily undergraduate institutions, community colleges, and tribally
controlled colleges and universities are allowed. A&R projects must be
relevant to the scope of the proposed research for faculty and students.

The number of awards is contingent upon NIH appropriations
and the submission of a sufficient number of meritorious applications.

Only
one award will be made per IDeA-eligible state.

Award Budget

Direct costs are limited to $2.5 million per year,
excluding facilities and administrative (F&A) costs on consortium
arrangements. In addition, this FOA will provide one-time funds of up to
$250,000 in direct costs in first year of award for alteration and renovation
to improve existing core laboratories, research laboratories and/or animal
facilities at the primarily undergraduate institutions, community colleges,
and tribally controlled colleges and universities. If alteration and
renovation costs are requested, then the budget request for year one must not
exceed $2.75 million in direct costs. Regardless of whether alteration and
renovation costs are requested, budget requests for years two through five
cannot exceed $2.5 million per year in direct costs, excluding F&A costs
on consortium arrangements.

Because the nature and scope of the proposed research will
vary from application to application, it is anticipated that the size and
duration of each award will also vary.

Award Project Period

The project period is limited to five years.

NIH grants policies as
described in the NIH Grants
Policy Statement will apply to the
applications submitted and awards made in response to this FOA.

Section III. Eligibility
Information

1. Eligible Applicants

Eligible Organizations

Higher Education Institutions

Public/State Controlled Institutions of Higher Education

Private Institutions of Higher Education

The following types of Higher Education Institutions
are always encouraged to apply for NIH support as Public or Private
Institutions of Higher Education:

Applicant organizations must complete and maintain the
following registrations as described in the SF 424 (R&R) Application Guide
to be eligible to apply for or receive an award. All registrations must be
completed prior to the application being submitted. Registration can take 6
weeks or more, so applicants should begin the registration process as soon as
possible. The NIH
Policy on Late Submission of Grant Applications states that failure to
complete registrations in advance of a due date is not a valid reason for a
late submission.

Dun and Bradstreet
Universal Numbering System (DUNS) - All registrations require that
applicants be issued a DUNS number. After obtaining a DUNS number, applicants
can begin both SAM and eRA Commons registrations. The same DUNS number must be
used for all registrations, as well as on the grant application.

System for Award Management (SAM) (formerly CCR) – Applicants must complete and maintain an active registration, which
requires renewal at least annually. The renewal process may require as much
time as the initial registration. SAM registration includes the assignment of a
Commercial and Government Entity (CAGE) Code for domestic organizations which
have not already been assigned a CAGE Code.

eRA Commons - Applicants
must have an active DUNS number and SAM registration in order to complete the
eRA Commons registration. Organizations can register with the eRA Commons as
they are working through their SAM or Grants.gov registration. eRA Commons
requires organizations to identify at least one Signing Official (SO) and at
least one Program Director/Principal Investigator (PD/PI) account in order to
submit an application.

Grants.gov – Applicants
must have an active DUNS number and SAM registration in order to complete the
Grants.gov registration.

Program
Directors/Principal Investigators (PD(s)/PI(s))

All PD(s)/PI(s) must have an eRA Commons account.
PD(s)/PI(s) should work with their organizational officials to either
create a new account or to affiliate their existing account with the applicant
organization in eRA Commons. If the PD/PI is also the organizational Signing
Official, they must have two distinct eRA Commons accounts, one for each role.
Obtaining an eRA Commons account can take up to 2 weeks.

Eligible Individuals (Program Director/Principal
Investigator)

Any individual(s) with the skills, knowledge, and resources
necessary to carry out the proposed research as the Program Director(s)/Principal
Investigator(s) (PD(s)/PI(s)) is invited to work with his/her organization to
develop an application for support. Individuals from underrepresented racial
and ethnic groups as well as individuals with disabilities are always
encouraged to apply for NIH support.

The goals of this program are accomplished through the
direction provided by a PD/PI at the lead institution, who has the primary
responsibility for administering the program and for overseeing the scientific
network and its associated core facilities. The PD/PI of the INBRE application
must be an established biomedical or behavioral research scientist with
expertise directly related to the research theme(s) of the grant application.
The PD/PI will ensure that high-quality research is performed and has the experience
to administer effectively and integrate all components of the program. The
PD/PI must have the requisite administrative experience and leadership skills
to direct this multi-faceted program.

The PD/PI at the lead institution will serve as the director
of the INBRE and will coordinate its activities.

PD(s)/PI(s) may not simultaneously lead two or more IDeA
program awards.

Only one application per institution (normally identified by
having a unique DUNS number or NIH IPF number) is allowed. Only one award will
be made per state.

The NIH will not accept duplicate or highly overlapping
applications under review at the same time. This means that the NIH will
not accept:

A new (A0) application that is submitted before issuance of the
summary statement from the review of an overlapping new (A0) or resubmission
(A1) application.

A resubmission (A1) application that is submitted before issuance
of the summary statement from the review of the previous new (A0) application.

An application that has substantial overlap with another
application pending appeal of initial peer review (see NOT-OD-11-101).

Section IV. Application and Submission Information

1. Requesting an
Application Package

A button to access the online ASSIST system is available in Part 1 of this FOA. See your
administrative office for instructions if you plan to use an institutional
system-to-system solution.

Most applicants will use NIH’s ASSIST system to prepare and
submit applications through Grants.gov to NIH. Applications prepared and
submitted using applicant systems capable of submitting electronic
multi-project applications to Grants.gov will also be accepted.

2. Content and Form of Application Submission

It is critical that applicants follow the Multi-Project (M) Instructions
in the SF424
(R&R) Application Guide, including Supplemental
Grant Application Instructions except where instructed in this funding
opportunity announcement to do otherwise and where instructions in the
Application Guide are directly related to the Grants.gov downloadable forms
currently used with most NIH opportunities. Conformance to the requirements in
the Application Guide is required and strictly enforced. Applications that are
out of compliance with these instructions may be delayed or not accepted for
review.

Although a letter of intent is not required, is not binding,
and does not enter into the review of a subsequent application, the information
that it contains allows IC staff to estimate the potential review workload and
plan the review.

By the date listed in Part 1. Overview
Information, prospective applicants are asked to submit a letter of intent
that includes the following information:

Additional page limits described in the SF424 Application
Guide and the Table of Page
Limits must be followed.

Instructions for the Submission of Multi-Component
Applications

The following section supplements the instructions found in
the SF424 (R&R) Application Guide, and should be used for preparing a
multi-component application.

The application should consist of the following components:

Overall: required

Administrative Core: required

Research Cores: optional

Bioinformatics Core: required

Developmental Research Project Program: required, maximum of 1

Alteration and Renovation: optional

Overall Component

When preparing your application in ASSIST, use Component
Type ‘Overall’.

All instructions in the SF424 (R&R) Application Guide
must be followed, with the following additional instructions, as noted.

SF424 (R&R) Cover (Overall)

Complete entire form.

PHS 398 Cover Page Supplement (Overall)

Note: Human Embryonic Stem Cell
lines from other components should be repeated in cell line table in Overall
component.

Research & Related Other
Project Information (Overall)

Follow standard instructions.

Facilities
and Other Resources: Resources including existing equipment,
instrumentation, collaborative resources and laboratory space at the lead and
network institutions to support INBRE research activities should be described.

Other
Attachments: Memorandum
of Understanding: A memorandum of understanding (MOU) must clearly describe the
arrangements between the network partner institutions and the lead
institution and must provide for release time for investigators. Faculty at
4-year baccalaureate institutions must have a commitment for 50% release time
(equivalent to 6.0 person months) for the conduct of research as part of the
MOU. Women, minorities and individuals with disabilities are strongly
encouraged to participate.

Project/Performance Site
Location(s) (Overall)

Enter primary site only.

A summary of Project/Performance
Sites in the Overall section of the assembled application image in eRA Commons
compiled from data collected in the other components will be generated upon
submission.

Research & Related
Senior/Key Person Profile (Overall)

Include only the Project
Director/Principal Investigator (PD/PI) and any multi-PDs/PIs (if applicable to
this FOA) for the entire application.

A summary of Senior/Key Persons
followed by their Biographical Sketches in the Overall section of the assembled
application image in eRA Commons will be generated upon submission.

Budget (Overall)

The only budget information
included in the Overall component is the Estimated Project Funding section of
the SF424 (R&R) Cover.

A budget summary in the Overall
section of the assembled application image in eRA Commons compiled from
detailed budget data collected in the other components will be generated upon
submission.

PHS 398 Research Plan (Overall)

Introduction to Application: For Resubmission applications, an Introduction to Application is required in
the Overall component.

Specific Aims: Provide
specific aims for the overall network.

Complete entire form.

Research
Strategy:

Progress
and Accomplishments:The renewal and resubmission renewal applications must provide
a description of progress and accomplishments made during the current INBRE in
the following areas:

Research Infrastructure as measured by improved research
facilities and support services, including bioinformatics in the research
network; acquisition and utilization of new and major instrumentation;

Research Environment as evidenced by successful recruitment of
science faculty from different disciplines at the institutions in the network;
increased collaboration among researchers and institutions;

Development of science curriculum (courses and programs) offered
at the network institutions;

Development of research laboratories and facilities in the
network institutions;

Students majoring in science and health-related fields;

Students and faculty participating in research activities;

Research Productivity as measured by scientific publications in
peer-reviewed journals and presentations at scientific meetings and other
conferences;

Grant applications from research intensive institutions for NIH
and other research grants submitted and awarded;

Number of undergraduate students pursuing science and
health-related careers;

Research projects completed in the prior grant period to
demonstrate past progress and/or support success of the program. This
information may be represented in a table format;

Impact on the state's workforce and economy;

Impact on students and faculty from primarily undergraduate
institutions, community colleges, and TCCUs as a pipeline into the graduate
science programs within the state;

Other metrics as defined by the applicant that demonstrate
accomplishments of participating institutions, faculty, and students in the network;
and

Any programmatic change(s)/corrective actions that occurred
during the current INBRE funding period as a result of evaluation.

Overall
Network Organization and Management Plan:The application must
provide an overall network organization and management plan. The important
elements that need to be included in the section are the following:

Justification of a five-year support for the thematic scientific
network which includes the proposed organization and component functions of the
INBRE;

A description of the priorities and objectives of the network.
The plan should demonstrate the applicant's knowledge, ingenuity, practicality,
and commitment to developing and maintaining a significant and productive
research program;

A description of organizational structure established for various
cores and the statewide network of baccalaureate/master's level degree-granting
institutions and community colleges and TCCUs that will provide the sites for
the conduct of the thematic, multidisciplinary, biomedical or behavioral
research;

A description of the plan for networking, sharing of resources
and cross-collaborations with COBRE, other INBREs, and other appropriate NIH
programs;

A description of the unique research opportunities that will be
provided to the project investigators at the lead and partner institutions; and

A description of how the efforts of project investigators and
core service facilities will assist in the establishment of a multidisciplinary
research network

Progress
Report Publication List: A list of publications produced from
INBRE should be included.

Letters of Support: While non-Federal matching
funds are not required, the application must show clear evidence of strong and
specific institutional commitment. It is recognized that the availability of
resources is variable among institutions. Consequently, the level of
institutional commitment will differ among applicant institutions. At a
minimum, the application should include communication from a senior institutional
official from the lead institution (e.g., President or Dean) outlining the
resources and facilities that will be committed by the institution to support
and sustain the INBRE program throughout the period of funding. Some examples
of institutional commitments that may be documented include financial support,
adequate space, release time agreements, core consolidation and maintenance. As
appropriate, letters of support with institutional commitment from partner
institutions in the network should also be included.

As appropriate, letters from the Program
Directors/Principal Investigators of other awardees of NIH and other Federal
and non-Federal entities (e.g., COBREs, IDeA-CTRs) may be included indicating
their program's role in supporting the INBRE's goals and objectives.

Resource
Sharing Plan: Individuals are required to comply with the
instructions for the Resource Sharing Plans as provided in the SF424 (R&R)
Application Guide.

Appendix: Do not use the
Appendix to circumvent page limits. Follow all instructions for the Appendix as
described in the SF424 (R&R) Application Guide.

PHS Assignment Request Form (Overall)

All instructions in the SF424
(R&R) Application Guide must be followed.

Project Narrative: Do not
complete. Note: ASSIST screens will show an asterisk for this attachment
indicating it is required. However, eRA systems only enforce this requirement
in the Overall component and applications will not receive an error if omitted
in other components.

Project /Performance Site
Location(s) (Administrative Core)

List all performance sites that
apply to the specific component.

Note: The Project Performance
Site form allows up to 300 sites, prior to using additional attachment for
additional entries.

Research & Related
Senior/Key Person Profile (Administrative Core)

In the Project Director/Principal Investigator section of the
form, use Project Role of ‘Other’ with Category of ‘Core Lead’ and provide a
valid eRA Commons ID in the Credential field.

In the additional Senior/Key Profiles section, list Senior/Key
persons that are working in the component.

Include a single Biographical Sketch for each Senior/Key person
listed in the application regardless of the number of components in which they
participate. When a Senior/Key person is listed in multiple components, the
Biographical Sketch can be included in any one component.

If more than 100 Senior/Key persons are included in a component,
the Additional Senior Key Person attachments should be used.

Budget (Administrative Core)

Budget forms appropriate for the specific component
will be included in the application package.

Funds will be provided to strengthen research
infrastructure and capacity at the lead and partner institutions, including
instrumentation for Core laboratories, optional cores such as for Community
Based Participatory Research, and support for investigators, postdoctoral
fellows, graduate and undergraduate students, students from community colleges
and TCCUs, and technical assistants.

The maximum allowable direct cost for the INBRE
program is $2.5 million per year of which $1.0 million is available to support
the Administrative and Bioinformatics Cores, Core facilities, career building
and enhancement activities, and research activities at the awardee institution
and at other research-intensive institutions in the network.

The remaining direct costs, up to a maximum of $1.5
million, are to be distributed among the participating network partner
institutions including baccalaureate/master's degree institutions, community
colleges, and TCCUs as consortium arrangements and/or subcontracts to build
infrastructure and research capacity for the proposed multidisciplinary
research projects. Funds allocated to partner institutions are to cover
expenses including but not limited to salary, research support, and equipment
acquisition. A maximum of 15% of the total direct cost requested at each
partner institution may be used for administrative costs. Funds allocated to
community colleges and TCCUs may be used to establish science programs/courses
and conduct meaningful research projects relevant to their communities during
the summer and academic year.

The applicant institution that is located in a state
that has no medical school and fewer than four additional accredited
undergraduate institutions that award degrees in both biology and chemistry,
may consider the budgetary allocation guidelines regarding the available $2.5
million direct costs to be flexible.

The Administrative Core Lead must devote a minimum
time commitment of 3.6 person months per year for career guidance and
administrative oversight of the INBRE; however, up to 6.0 person months will be
supported.

Support will be provided at 3.6 - 6.0 person months
annually for an additional faculty within the INBRE network to serve as a
Program Coordinator.

It is not required or expected that each applicant
will request the categorical maximum allowable costs stated herein. These
numbers are provided as a guide for purposes of developing the INBRE network.
The actual costs requested will be based on the INBRE network (i.e., number of
participating institutions) and activities (i.e., number of scientific projects
in the Developmental Research Project Program, core support costs) providing
the justification for the appropriate expenditure of proposed costs.

Salary costs are allowable to the extent that they
are reasonable; conform to the established policy of the organization
consistently applied regardless of the source of funds; and reflect no more
than the percentage of time actually devoted to the NIH-funded project. If
full-time 12-month salaries are not currently paid to comparable staff members,
the salary proposed must be appropriately related to the existing salary.

There will be an annual meeting of the leadership of
the grantee networks with NIGMS staff in Bethesda, Maryland. The costs to
attend this meeting should be included in the travel budget of the application.
Estimate the costs for key staff to attend this meeting annually. The key staff
may include PD/PI, PC and Bioinformatics Core Director. These meetings will
provide a forum for the exchange of ideas, information and address their
concerns, needs and problems that arise. In addition, NIH staff will provide
updates on program, policies and regulations that relate to the conduct of
research.

If requesting items that are normally treated as
F&A costs (for example, general office supplies) as direct costs, the
applicant must provide a strong justification for those items and demonstrate
that the cost is commensurate with the benefit that particular item of cost
will have on the associated project. Failure to adequately justify such costs
will likely result in their deletion from the requested budget.

Tuition Remission and other forms of compensation
paid as, or in lieu of, wages to students are allowable provided:

The individual is performing activities necessary to the grant;

Tuition remission and other forms of compensation are provided in
accordance with established institutional policy, consistently provided to
students performing similar activities conducted in non-sponsored as well as in
sponsored activities; and

During the academic period, the student is enrolled in an
advanced degree program at a grantee or affiliated institution and the
activities of the student in relation to the federally sponsored research
project are related to the degree program.

"Stipends" as defined by the NIH are an
allowable cost of living allowance for trainees and fellows only under
Kirschstein-NRSA individual fellowships and institutional research training
grants and are NOT allowable for this initiative. “Compensation of Students”
however is an allowable cost on the grant.

Salary and research support will be provided for
participating graduate, undergraduate and community college and TCCUs students,
and postdoctoral fellows.

Expenses of the External Advisory Committee (EAC),
including travel and consultant fee, should be included in the budget request.

While the PD/PI and PC positions are considered
mandatory for carrying out the INBRE mission, support for other scientific or
staff positions can also be requested as long as their role in the program is
justified.

The INBRE must have an independent, external evaluation
in addition to the monitoring and formative evaluation process provided
internally and by the External Advisory Committee.

Funds for the external evaluation, up to 2% of the
total direct costs, if appropriately justified, may be requested in the Administrative
Core budget.

Collaborations between or among IDeA eligible states
as well as collaborations with institutions in other non-IDeA states are
allowable. However, grant funds awarded to an IDeA-eligible institution may not
be transferred via subcontract to a non-IDeA state. IDeA funds may be used in
other IDeA and non-IDeA states for fee-for-service activities, such as attending
instructional activities and learning new techniques, sample and data analyses,
workshops and compensating for scientific career advice and career enhancement efforts,
etc.

The program may support development and
implementation of curricular activities aimed at broadening experience to
better prepare students for research careers in a variety of venues, such as
academia, industry, government or entrepreneurial enterprises.

Sharing resources among INBRE and COBRE investigators
is strongly encouraged. If a core facility already exists for equipment and
instrumentation supported by a COBRE program, these should not be proposed de
novo in the INBRE application. However, if duplicate equipment is to be
requested under this FOA, it should be appropriately justified.

Other Allowable Costs include:

Salary support for a Program Coordinator and other scientific or
staff positions;

Salary support for an administrative assistant if required and
justified;

Research equipment and instrumentation for laboratories;

Supplies for research.

A detailed justification for each item requested,
including personnel, supplies, and equipment, must be provided.

The PD/PI of the INBRE is not eligible for research
project support, nor can he/she use INBRE funds to supplement research
activities within his/her laboratory.

Note: The R&R Budget form
included in many of the component types allows for up to 100 Senior/Key Persons
in section A and 100 Equipment Items in section C prior to using attachments
for additional entries. All other SF424 (R&R) instructions apply.

PHS 398 Research Plan (Administrative
Core)

Introduction
to Application: For Resubmission applications, an Introduction
to Application is allowed for the Administrative Core component. The
Introduction should include responses to the criticisms and issues raised in
the prior Summary Statement and summarize the substantial additions, deletions,
and changes.

Specific Aims: The SF424 application
Guide must be followed

Research Strategy: The important elements
that must be included in this section include the following:

Qualifications and role of the Administrative Core Lead and Project
Coordinator that are not reflected in the biosketch. The PC may be selected
from among the participating institutions in the proposed scientific network.

A description of administrative structure of the network and
arrangements and the mechanisms to be used to resolve differences of opinion
among network partner institutions.

Career enhancement plans for faculty investigators at partner
institutions. This should involve oversight by established senior faculty
members assigned as science advisors, constructive evaluations provided by
members of the Steering Committee and External Advisory Committee coordinated
by the Administrative Core Lead. Describe how faculty investigators will be
protected for release time for research. In some cases, COBRE investigators,
where appropriate, may serve as science advisors to INBRE investigators and/or
students.

The network's plan to develop the research skills of both
graduate and undergraduate students and faculty. The plans should include the
role of the undergraduate faculty.

Plans to attract and retain promising students into
biomedically-related science majors and opportunities for exposure to
cutting-edge research.

A description of infrastructure needs at the INBRE partner
institutions and how the Administrative Core will prioritize those
infrastructure needs.

A description of External Advisory Committee, including the
number and types of individuals to be included and their professional
qualifications. Only the established External Advisory Committee members should
be identified and named in the application. However, potential new members
should not be contacted or identified.

Roles of the INBRE Steering Committee and External Advisory
Committee in establishing the approaches to set priorities for future research
efforts in primarily undergraduate and graduate institutions, community
colleges, and TCCUs.

A description of the development and implementation of the plan
for formative and summative evaluations of the network along with strategies
for implementing required network modifications, if deemed necessary. The
evaluation plan should assess whether the effectiveness of the approach taken
will meet the goals or benchmarks for building an effective institutional and
statewide scientific network. The evaluation plan should set benchmarks for the
overall network's impact on:

- elements such as enhancement of research
infrastructure and environment, quality and number of students, productivity of
the investigators, and impact on the state's biotechnology industry, economy
and workforce; and

- recruitment and retention of outstanding faculty
and students at participating undergraduate and graduate institutions,
community colleges and TCCUs.

Letters of Support: Letters indicating
institutional commitment and any letter of support for the proposed
Administrative Core should be included.

Resource
Sharing Plan: Individuals are required to comply with the
instructions for the Resource Sharing Plans as provided in the SF424 (R&R)
Application Guide.

Appendix: Do not use the Appendix to
circumvent page limits. Follow all instructions for the Appendix as described
in the SF424 (R&R) Application Guide.

PHS Inclusion Enrollment
Report (Administrative Core)

Form only available in FORMS-D application packages for use with due dates on or before January 24, 2018.

When conducting clinical research, follow all instructions for completing PHS Inclusion Enrollment Report
as described in the
SF424 (R&R) Application Guide.

Bioinformatics Core

When preparing your application in ASSIST, use Component
Type ‘Core.’

All instructions in the SF424 (R&R) Application Guide
must be followed, with the following additional instructions, as noted.

Project
Narrative: Do not complete. Note: ASSIST screens will show an
asterisk for this attachment indicating it is required. However, eRA systems
only enforce this requirement in the Overall component and applications will
not receive an error if omitted in other components.

Project /Performance Site Location(s)
(Bioinformatics Core)

List all performance sites that apply to the specific
component.

Note:
The Project Performance Site form allows up to 300 sites, prior to using
additional attachment for additional entries.

Research & Related Senior/Key
Person Profile (Bioinformatics Core)

In the Project Director/Principal Investigator section of the
form, use Project Role of ‘Other’ with Category of ‘Core Director’ and provide
a valid eRA Commons ID in the Credential field.

In the additional Senior/Key Profiles section, list Senior/Key
persons that are working in the component.

Include a single Biographical Sketch for each Senior/Key person
listed in the application regardless of the number of components in which they
participate. When a Senior/Key person is listed in multiple components, the
Biographical Sketch can be included in any one component.

If more than 100 Senior/Key persons are included in a component,
the Additional Senior Key Person attachments should be used.

The Core Director(s) of Bioinformatics Core must be
experienced personnel with the requisite stature, knowledge, authority,
leadership, and administrative skills and capabilities to direct the resource.
The Core Director will lead a team of specialists in the specific area of service
to: (1) develop plans for standard operating procedures governing the
utilization and management of core expertise and resources; and (2) develop
plans for disseminating information, training, and serving as subject matter
experts to investigators.

Budget (Bioinformatics Core)

Budget forms appropriate for the specific component
will be included in the application package.

A detailed budget for the entire proposed project
period (5 years) must be provided.

Note:
The R&R Budget form included in many of the component types allows for up
to 100 Senior/Key Persons in section A and 100 Equipment Items in section C
prior to using attachments for additional entries. All other SF424 (R&R)
instructions apply.

PHS 398 Research Plan (Bioinformatics
Core)

Introduction
to Application: For Resubmission applications, an Introduction
to Application is allowed for the Bioinformatics Core component. The
introduction should include responses to the criticisms and issues raised in
the prior Summary Statement and summarize the substantial additions, deletions,
and changes.

Specific
Aims: The SF424 application Guide must be followed.

Research
Strategy:The important elements that must be
included in this section are the following:

Progress made by the Bioinformatics Core in creating
infrastructure and other related tools for investigators in the network during
INBRE.

A description of impact of the Core on multidisciplinary thematic
research efforts and the environment in which to develop a new generation of
researchers and how the Core will serve the scientific needs of the individual pilot
projects.

A description of new approaches to be undertaken within the
proposed scientific network to provide access to bioinformatics tools for data
mining and model development, database management and the need for training
investigators in the effective use of those tools.

If access to high-end computational power is required, describe
how and where investigators can access this capability.

A description of operating procedures of the Core.

Letters
of Support: Letters indicating institutional commitment to
support and maintain the Core and any letter of support for the proposed
Bioinformatics Core should be included.

Resource
Sharing Plan: Individuals are required to comply with the
instructions for the Resource Sharing Plans as provided in the SF424 (R&R)
Application Guide.

Appendix: Do not use the Appendix to circumvent page limits. Follow all
instructions for the Appendix as described in the SF424 (R&R) Application
Guide.

PHS Inclusion Enrollment Report (Bioinformatics
Core)

Form only available in FORMS-D application packages for use with due dates on or before January 24, 2018.

When conducting clinical research, follow all instructions for completing PHS Inclusion Enrollment Report
as described in the
SF424 (R&R) Application Guide.

Research Cores

When preparing your application in ASSIST, use Component
Type ‘Core.’

All instructions in the SF424 (R&R) Application Guide
must be followed, with the following additional instructions, as noted.

If core research resources are requested, they must be for
multiple users, including infrastructure applicable to various disciplines in
the lead or partner institutions for the benefit of researchers and research
projects.

Project
Narrative: Do not complete. Note: ASSIST screens will show an
asterisk for this attachment indicating it is required. However, eRA systems
only enforce this requirement in the Overall component and applications will
not receive an error if omitted in other components.

Facilities
and Other Resources: The applicants should describe the
scientific environment including physical resources in which the research will
be done. A description of the major existing equipment and instrumentation for
conducting research should be provided.

Project /Performance Site Location(s)
(Research Core)

List all performance sites that apply to the specific
component.

Note:
The Project Performance Site form allows up to 300 sites, prior to using
additional attachment for additional entries.

Research & Related Senior/Key
Person Profile (Research Core)

In the Project Director/Principal Investigator section of the
form, use Project Role of ‘Other’ with Category of ‘Core Director’ and provide
a valid eRA Commons ID in the Credential field.

In the additional Senior/Key Profiles section, list Senior/Key
persons that are working in the component.

Include a single Biographical Sketch for each Senior/Key person
listed in the application regardless of the number of components in which they
participate. When a Senior/Key person is listed in multiple components, the
Biographical Sketch can be included in any one component.

If more than 100 Senior/Key persons are included in a component,
the Additional Senior Key Person attachments should be used.

Qualifications
and Responsibilities of Core Director(s)

The Core Director(s) of a research core facility must
be experienced personnel with the requisite stature, knowledge, authority,
leadership, and administrative skills and capabilities to direct the resource.
The Core Director will lead a team of specialists in the specific area of
service to: (1) develop plans for standard operating procedures governing the
utilization and management of core expertise and resources; (2) develop plans
for disseminating information, training, and serving as subject matter experts
to investigators; (3) maintain state-of-the-art technologies and knowledge
capabilities; and (4) recommend to the INBRE PD(s)/PI(s) any updates and/or
replacement of equipment or personnel.

Budget (Research Core)

Funds may be requested to establish core facilities.
In addition to personnel and supply costs, the acquisition of new equipment and
modernization of instrumentation may be proposed. Salaries for support and
technical staff as well as professional staff who will direct Cores should be
included.

A detailed budget for the entire proposed project
period (5 years) must be proposed.

The level of support requested must be justified by
the projected use by researchers from the lead or partner institutions.

Note:
The R&R Budget form included in many of the component types allows for up
to 100 Senior/Key Persons in section A and 100 Equipment Items in section C
prior to using attachments for additional entries. All other SF424 (R&R)
instructions apply.

PHS 398 Research Plan (Research Core)

Introduction
to Application: For Resubmission applications, an Introduction
to Application is allowed for the Research Core component. The introduction
should include responses to the criticisms and issues raised in the prior
Summary Statement and summarize the substantial additions, deletions, and
changes.

Specific
Aims: The SF424 application Guide must be followed.

Research
Strategy: The important elements that need to be included in
this section are the following:

A description of the impact of proposed core on the development
of the network and how they will serve and facilitate the scientific needs of
the proposed developmental research project program.

A description of plans to recruit personnel to operate the core,
if needed. Provide the rationale for continuing existing INBRE-supported Core
facilities or for adding new Core facilities.

Justification of additional research instrumentation needs of the
INBRE partner institutions and how those needs can be addressed through this
program.

A description of how the core will be operated. The
applicant should describe the standard operating procedures of each core, how
state-of-the-art techniques will be maintained, how quality control will be
managed, how disputes concerning core usage will be resolved, and how research
investigators will be trained in the capabilities of the core and the
techniques required.

A description of proposed business plan for operation of the Core
including prioritization of the service requests and charge back fees for
non-INBRE users.

Letters
of Support: Letters indicating institutional commitment to
support and maintain the Core and any letter of support for the proposed core
should be included.

Resource
Sharing Plan: Individuals are required to comply with the
instructions for the Resource Sharing Plans as provided in the SF424 (R&R)
Application Guide.

Appendix: Do not use the Appendix to circumvent page limits. Follow all
instructions for the Appendix as described in the SF424 (R&R) Application
Guide.

PHS Inclusion Enrollment Report (Research
Core)

Form only available in FORMS-D application packages for use with due dates on or before January 24, 2018.

When conducting clinical research, follow all instructions for completing PHS Inclusion Enrollment Report
as described in the
SF424 (R&R) Application Guide.

Developmental Research Project Program

When preparing your application in ASSIST, use Component
Type ‘Project.’

All instructions in the SF424 (R&R) Application Guide
must be followed, with the following additional instructions, as noted.

Project
Narrative: Do not complete. Note: ASSIST screens will show an
asterisk for this attachment indicating it is required. However, eRA systems
only enforce this requirement in the Overall component and applications will
not receive an error if omitted in other components.

In the Project Director/Principal Investigator section of the
form, use Project Role of ‘Other’ with Category of ‘Project Lead’ and provide a
valid eRA Commons ID in the Credential field.

In the additional Senior/Key Profiles section, list Senior/Key
persons that are working in the component.

Include a single Biographical Sketch for each Senior/Key person
listed in the application regardless of the number of components in which they
participate. When a Senior/Key person is listed in multiple components, the
Biographical Sketch can be included in any one component.

If more than 100 Senior/Key persons are included in a component,
the Additional Senior Key Person attachments should be used.

Budget (Developmental Research
Project Program)

Budget forms appropriate for the specific component
will be included in the application package.

Science advisors may be supported for up to 2.4
person months if he/she will be extensively involved in interacting directly
with and providing career enhancement to the faculty, investigators and students
at the primarily undergraduate institutions, community colleges and TCCUs.

Individual projects in the Developmental Research
Project Program may be funded at a level not to exceed $125,000 per year in
direct costs.

It is expected that the research project
investigators at the awardee and network partner institutions will devote at
least 50 percent of their professional effort (equivalent to 6.0 person months)
to career development and research activities. Institutions must provide
release time for project investigators, thus permitting a significant time
commitment to the research enterprise. To allow flexibility to investigators
who cannot devote 6.0 consecutive months throughout the year, the effort can be
distributed over the year to achieve a total of 6 person months (for example,
3.0 person months during academic year and 3.0 person months in summer (up to
three months) to account for a yearly 6.0 person months effort).

The COBRE and IDeA-CTR investigators are not eligible
for research funding from INBRE as project investigators. Similarly, INBRE
investigators may not receive simultaneous research project support from a
COBRE or IDeA-CTR program. COBRE and IDeA-CTR investigators may serve and be
supported as science advisors or collaborators in INBRE programs as
appropriate.

Note:
The R&R Budget form included in many of the component types allows for up
to 100 Senior/Key Persons in section A and 100 Equipment Items in section C
prior to using attachments for additional entries. All other SF424 (R&R)
instructions apply.

PHS 398 Research Plan (Developmental
Research Project Program)

Introduction
to Application:For Resubmission applications, an Introduction to Application
is allowed for the Developmental Research Project Program component. The Introduction
should include responses to the criticisms and issues raised in the prior
Summary Statement and summarize the substantial additions, deletions, and
changes.

Specific
Aims:The
SF424 application Guide must be followed.

Research
Strategy: Applicants should not propose individual research
projects in the application. The important elements that must be included in
this section are the following:

A description of an internal mechanism (internal Funding
Opportunity Announcement) for obtaining and awarding multidisciplinary
developmental research projects.

A description of the scope; eligibility requirements; the limit
on the dollars available and the number of years of support per project; the
solicitation, submission, review, and selection criteria and process;
prioritization of the projects and review of their methodology and research
performance, oversight and evaluation procedures; and a defined procedure and
organizational structure to provide assurance that all projects supported from
this grant will be in full compliance with all applicable Federal policies,
rules, and guidelines for research involving human subjects, vertebrate
animals, and/or biohazards as described in the SF424 (R&R) Application
Guide.

A general career enhancement plan.

Letters
of Support: Letters indicating institutional commitment to
support the Developmental Research Project Program and any letters of
commitment from science advisors and/or from collaborators and/or consultants
for the proposed program should be included.

Resource
Sharing Plan: Individuals are required to comply with the
instructions for the Resource Sharing Plans as provided in the SF424 (R&R)
Application Guide.

Appendix: Do not use the Appendix to circumvent page limits. Follow all
instructions for the Appendix as described in the SF424 (R&R) Application
Guide.

Project
Narrative: Do not complete. Note: ASSIST screens will show an
asterisk for this attachment indicating it is required. However, eRA systems
only enforce this requirement in the Overall component and applications will
not receive an error if omitted in other components.

Other
Attachments: Line drawings should be submitted as described
below:

Submit line drawings on 8-1/2" x 11" paper only as PDFs.
(DO NOT SUBMIT BLUEPRINTS.) All floor plans must be legible, with the scale
clearly indicated.

The line drawings of the proposed renovation must be at a scale
adequate to explain the project. The drawings should indicate size
(dimensions), function, and net and gross square feet of space for each room.
The total net and gross square feet of space to be renovated should also be
given.

The floor plan should indicate the location of the proposed
renovation area in the building.

Include the as-built drawings of the proposed renovation area and
indicate any areas that will be demolished.

Project /Performance Site Location(s)
(Alteration and Renovation)

List all performance sites that apply to the specific
component.

Note:
The Project Performance Site form allows up to 300 sites, prior to using
additional attachment for additional entries.

In the Project Director/Principal Investigator section of the
form, use Project Role of ‘Other’ with Category of ‘Project Lead’ and provide a
valid eRA Commons ID in the Credential field.

In the additional Senior/Key Profiles section, list Senior/Key
persons that are working in the component.

Include a single Biographical Sketch for each Senior/Key person
listed in the application regardless of the number of components in which they
participate. When a Senior/Key person is listed in multiple components, the
Biographical Sketch can be included in any one component.

If more than 100 Senior/Key persons are included in a component,
the Additional Senior Key Person attachments should be used.

Budget (Alteration and Renovation)

Budget forms appropriate for the specific component
will be included in the application package.

Alteration and Renovation (A&R) costs to improve
existing core laboratories and/or research laboratories at the primarily
undergraduate institutions, and community colleges and TCCUs are allowed up to
$250,000 in direct costs only in year one of the award as a one-time cost
expenditure. Direct costs requested for A&R are not subject to facilities
and administrative costs (F&A). A&R costs will be approved for
facilities improvements ONLY at the consortia sites (the primarily
undergraduate institutions, community colleges and TCCUs). All alteration and
renovation must be complete within three years of the award.

Sufficient details must be provided to estimate the
cost and suitability of the project. Failure to adequately justify A&R
requests will likely result in their deletion from the requested budget.
A&R funds provided under this FOA cannot support new construction,
including completion of shell space, or the purchase of movable research
equipment or instrumentation or equipment intended for teaching or other
non-research related purposes.

An itemized budget and justification of the impact
that this alteration and renovation would have on the INBRE activities for
faculty and students must be provided. Provide justification of all fixed
equipment items requested for the renovated area.

Note:
The R&R Budget form included in many of the component types allows for up
to 100 Senior/Key Persons in section A and 100 Equipment Items in section C
prior to using attachments for additional entries. All other SF424 (R&R)
instructions apply.

PHS 398 Research Plan (Alteration and
Renovation)

Introduction
to Application: For Resubmission applications, an Introduction
to Application is allowed for Alteration and Renovation component. The
Introduction should include responses to the criticisms and issues raised in
the prior Summary Statement and summarize the substantial additions, deletions,
and changes.

Specific
Aims:The SF424 application
Guide must be followed.

Research
Strategy: A narrative summary as outlined below must be
provided:

A description of how proposed renovations relate to the research
projects that will use the facility. If renovations to animal facilities are proposed,
they should be related to the projected animal populations (by species) in the
proposed projects. If renovations to animal facilities are proposed, include
the lines of authority and responsibility for administering the institution's
animal care and use program. The role and composition of the Institutional
Animal Care and Use Committee (IACUC) and how compliance with relevant laws,
policies, and guidelines are achieved should also be included.

List the functional modules, including the size (dimensions) and
square footage of each module (room, alcove, or cubicle) that will be directly
affected by the renovation project.

List engineering criteria applicable to each module (mechanical,
electrical, and utilities). Include information such as the number of air
changes per hour, electrical power, light levels, hot and cold water, and
steam.

Changes or additions to existing mechanical and electrical
systems should be clearly described in notes made directly on the plan or
attached to the plan.

Indicate the type(s) of new finishes to be applied to room
surfaces.

Letters
of Support: Letters indicating institutional commitment and any
letter of support for the proposed alteration and renovation should be
included.

Resource
Sharing Plan: Not required for this component.

Appendix: Do not use the Appendix to circumvent page limits. Follow all
instructions for the Appendix as described in the SF424 (R&R) Application
Guide.

PHS Inclusion Enrollment Report (Alteration
and Renovation)

Not Applicable

3. Unique Entity Identifier
and System for Award Management (SAM)

See Part 1. Section III.1 for information regarding the
requirement for obtaining a unique entity identifier and for completing and
maintaining active registrations in System for Award Management (SAM), NATO
Commercial and Government Entity (NCAGE) Code (if applicable), eRA Commons, and
Grants.gov.

4. Submission Dates and
Times

Part I. Overview Information contains information about Key Dates and times. Applicants are encouraged to
submit applications before the due date to ensure they have time to make any
application corrections that might be necessary for successful submission. When
a submission date falls on a weekend or Federal
holiday, the application deadline is automatically extended to the next
business day.

Organizations must submit applications to Grants.gov (the online portal to find and apply for grants
across all Federal agencies) using ASSIST or other electronic submission
systems. Applicants must then complete the submission process by tracking the
status of the application in the eRA Commons, NIH’s electronic system for grants
administration. NIH and Grants.gov systems check the application against many
of the application instructions upon submission. Errors must be corrected and a
changed/corrected application must be submitted to Grants.gov on or before the
application due date and time. If a Changed/Corrected application is submitted
after the deadline, the application will be considered late. Applications that
miss the due date and time are subjected to the NIH Policy on Late Application
Submission.

Applicants
are responsible for viewing their application before the due date in the eRA
Commons to ensure accurate and successful submission.

Information on the submission process and a definition of
on-time submission are provided in the SF424 (R&R) Application Guide.

For assistance with your electronic application or for more information on the electronic submission
process, visit Applying
Electronically. If you encounter a system issue beyond your control that
threatens your ability to complete the submission process on-time, you must
follow the Guidelines
for Applicants Experiencing System Issues. For assistance with application
submission, contact the Application Submission Contacts in Section VII.

Important reminders:

All PD(s)/PI(s) and component
Project Leads must include their eRA Commons ID in the Credential fieldof
the Senior/Key Person Profile Component of the SF424(R&R) Application Package. Failure to register in the Commons and to include a valid PD/PI Commons ID
in the credential field will prevent the successful submission of an electronic
application to NIH.

The applicant organization must
ensure that the DUNS number it provides on the application is the same number
used in the organization’s profile in the eRA Commons and for the System for
Award Management (SAM). Additional information may be found in the SF424
(R&R) Application Guide.

Applicants are required to follow the instructions for
post-submission materials, as described in the policy.

Section V. Application Review Information

1.
Criteria

Only the review criteria described below will be considered
in the review process. As part of the NIH mission,
all applications submitted to the NIH in support of biomedical and behavioral
research are evaluated for scientific and technical merit through the NIH peer
review system.

For this announcement, note the following:

The INBRE program is to augment and strengthen the biomedical
research capacity of an IDeA-eligible state. The review of an INBRE application
is additionally based on the qualification and stature of the PD(s)/PI(s) to
provide both scientific and administrative leadership and on the feasibility
and potential for investigators to obtain independent grant support and provide
research experiences to students to develop a pipeline to health research
careers.

Overall Impact - Overall

Reviewers will provide an overall impact score to reflect
their assessment of the likelihood for the INBRE network to exert a sustained,
powerful influence on the research field(s) involved, in consideration of the
following review criteria and additional review criteria (as applicable for the
INBRE network proposed).

Scored Review Criteria - Overall
Network Application

Reviewers will consider each of the review criteria below in
the determination of scientific merit, and give a separate score for each. An
application does not need to be strong in all categories to be judged likely to
have major scientific impact. For example, a network that by its nature is not
innovative may be essential to advance a field.

Significance

Does the network address an
important problem or a critical barrier to progress in the field? Is there a
strong scientific premise for the project? If the aims of the network are
achieved, how will scientific knowledge, technical capability, and/or clinical
practice be improved? How will successful completion of the aims change the
concepts, methods, technologies, treatments, services, or preventative
interventions that drive this field?

Are the overall network vision and
strategy adequate to continue to build a multi-disciplinary research network?
Will the proposed INBRE network augment and strengthen the IDeA-eligible
state's biomedical research capacity at the lead and partner institutions?

Investigator(s)

Are the PD(s)/PI(s), collaborators,
and other researchers well suited to the program? If Early Stage Investigators
or
those in the early stages
of independent careers, do they
have appropriate experience and training? If established, have they
demonstrated an ongoing record of accomplishments that have advanced their
field(s)? If the project is collaborative or multi-PD/PI, do the investigators have
complementary and integrated expertise; are their leadership approach,
governance and organizational structure appropriate for the project?

Do(es) the PD(s)/PI(s) have the
qualifications and skills to provide scientific and administrative leadership in
developing and directing the INBRE, and to continue building on the established
thematic, multi-disciplinary research network with a scientific focus?

Do the PD(s)/PI(s) and PC have the
experience and committed time to administer the proposed INBRE program? Do the
program leadership and management team bring complementary and integrated
expertise to the network?

Have the PD(s)/PI(s) shown
effective leadership in developing, directing and enhancing activities of the
Cores and network? Do the PD(s)/PI(s) present a plan for the continued
development of investigators and faculty, students and postdoctoral fellows in
the network? Do the PD(s)/PI(s) demonstrate leadership by showing that the
infrastructure necessary for the proposed network (e.g., facility improvements,
modernization/acquisition of equipment, implementation of administrative
resources, etc.) is in place, and that the network is committed to support the
resources and infrastructure?

Will the proposed INBRE program
have the professional staffing to benefit significantly the overall network and
quality of biomedical research? Do the Directors of the cores have the
appropriate training, experience and resources to assume leadership roles? Have
the core Directors committed sufficient time to this Program? Will the core
Directors have the authority to implement best practices identified by the
INBRE Steering Committee? Are the administrative and professional staff
appropriately trained and well suited to carry out this work?

Innovation

Does the application challenge and
seek to shift current research or clinical practice paradigms by utilizing
novel theoretical concepts, approaches or methodologies, instrumentation, or
interventions? Are the concepts, approaches or methodologies, instrumentation, or
interventions novel to one field of research or novel in a broad sense? Is a
refinement, improvement, or new application of theoretical concepts, approaches
or methodologies, instrumentation, or interventions proposed?

Is the network likely to develop novel
approaches to increasing the research opportunities for faculty, postdoctoral
fellows, graduate students and undergraduate students at the participating
institutions?

Approach

Are the overall strategy,
methodology, and analyses well-reasoned and appropriate to accomplish the
specific aims of the network? Have the investigators presented strategies to
ensure a robust and unbiased approach, as appropriate for the work proposed? Are
potential problems, alternative strategies, and benchmarks for success presented?
If the project is in the early stages of development, will the strategy
establish feasibility and will particularly risky aspects be managed? Have the
investigators presented adequate plans to address relevant biological
variables, such as sex, for studies in vertebrate animals or human subjects?

If the network involves human
subjects and/or NIH-defined clinical research, are the plans to address 1) the
protection of human subjects from research risks, and 2) inclusion (or
exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as
well as the inclusion or exclusion of children, justified in terms of the
scientific goals and research strategy proposed?

Will the proposed INBRE activities
include relevant scientific disciplines and collaborations to strengthen the
network and increase the productivity?

Environment

Will the scientific environment in
which the work will be done contribute to the probability of success? Are the
institutional support, equipment and other physical resources available to the
investigators adequate for the project proposed? Will the project benefit from
unique features of the scientific environment, subject populations, or
collaborative arrangements?

Are environment and institutional
support necessary for the resources committed by the institution(s) for the
INBRE appropriate?

Will the INBRE program enhance,
complement, and extend the applicant's current resources for biomedical
research to address health concerns and provide research opportunities to
students and faculty in the participating institutions?

Review Criteria for Components

Each of the following components of the application will be
assessed and given a score; the component scores will also be considered in
assigning an Overall Impact score to the overall application.

Administrative Core

Are plans to direct and manage the research training,
career development and enhancement of investigators, postdoctoral fellows and
students of the institutions involved in the network appropriate? Will these
plans be effective in meeting the program's goals? If there are plans to
recruit new faculty at the lead or partner institutions, are these plans
reasonable and suitable and consistent with the effective growth and
development of the network to make meaningful and significant contributions?

Are plans to undertake capacity building at the lead
and participating institutions in the network appropriate and reasonable?

Is the quality of the plan to develop an effective
research network for faculty and students that will contribute significantly to
the state's research base appropriate?

Will the External Advisory Committee be constituted
to provide critical, stimulating, and thoughtful advice for the overall network
performance?

Are the structure, composition and organizational
plans for the External Advisory Committee and Steering Committee to effectively
provide advice and recommendations to the participating institutions in the
network appropriate?

Are evaluation strategies to achieve the specific
goals of the INBRE program appropriate and suitable? Are there appropriate and
suitable evaluation strategies and specific milestones to measure progress, not
only of the investigators, but of the network as a whole, toward attaining its
long-range goals? In addition to the SC and EAC, does the applicant identify an
independent external evaluator, not a part of the INBRE, who will perform the
evaluation?

Bioinformatics Core

Are key personnel and the Core Director qualified to
lead in developing and enhancing research activities of the Core?

Are plans for familiarizing investigators and
students with bioinformatics tools and resources appropriate?

Developmental Research Project
Program

Is the Developmental Research/Pilot Program well
integrated into the overall INBRE goals and objectives? Is the program designed
to serve the needs of investigators from a variety of research areas? Will the
expected benefits to the lead and partner institutions be measured and tracked?

Is there an adequate plan to solicit proposals, to
prioritize the projects and to review their methodology and research
performance? Are plans adequate to assure compliance with applicable federal
policies and guidelines for research and research protections?

Is there a pool of qualified investigators from
network institutions to solicit applications? Are the plans for constituting
the review panel, their qualifications and expertise, appropriate to evaluate
research/pilot project applications?

Research Core Facilities (if included)

Are the proposed Research Core Facilities appropriate
to the needs of the overall program? Will the proposed core enhance the
statewide network research effort?

Are quality control processes (including procedures,
techniques, and quality control) proposed for the facilities or services
provided by the Research Core adequate? Are the criteria for prioritization and
usage of Core products and/or services appropriate?

Are the qualifications, experience, and commitment of
the Research Core Director and other key personnel adequate and appropriate for
providing the proposed facilities or services?

Will the proposed Research Core Facility provide
cost-effective services to the Network?

Is the environment for the Research Core Facility
adequate to support the Network as proposed? Does the applicant indicate any
institutional commitment to support and maintain the ongoing and proposed core
facilities/services?

Community Engagement and Outreach Core
(if included)

Are there clear and detailed plans for identifying a
health issue that fits community priorities and academic capacity to respond? Is
the proposed core appropriate to the needs of the program?

Are the plans for developing a coalition of community
and academic stakeholders and for implementing evaluation strategies for the
proposed projects appropriate?

Are the qualifications, experience, and commitment of
the Core Director and other key personnel adequate and appropriate for
providing the proposed facilities or services?

Alteration and Renovation (if
included)

Scientific Needs: Are
requested alteration and renovation projects relevant to the scope of the
proposed research? Are the costs and suitability of the project justified? If
renovations to animal facilities are proposed, do the proposed renovations
relate to the projected animal populations (by species)? If renovations to
animal facilities are proposed, are the lines of authority and responsibility
for administering the institution's animal care and use program indicated?

Architectural Plans: Are
the projected costs commensurate with the architectural plans for the proposed
A&R? Are there lists of the functional components, including the size
(dimensions) and square footage of each component (room, alcove or cubicle)
that will be directly affected by the renovation project? Are there appropriate
descriptions of the engineering criteria applicable to each component
(mechanical, electrical, and utilities) including information such as the
number of air changes per hour, electrical power, light levels, hot and cold
water, and steam, as well as the appropriate architectural criteria (such as
width of corridors and doors, surface finishes)? Is justification provided for
all fixed equipment items requested for the renovated area?

Are legible line drawings provided for all floor
plans with the scale clearly indicated? Are the line drawings of the proposed
renovation drawn to a scale adequate to explain the project? Do the drawings
indicate size (dimensions), function, and net and gross square feet of space
for each room? Are the total net and gross square feet of space to be renovated
provided? Does the plan indicate the location of the proposed renovation area
in the building? Does the plan include the as-built drawings of the proposed renovation
area and indicate any areas that will be demolished? Do the plans indicate
changes or additions to existing mechanical and electrical systems in notes
made directly on the plan or attached to the plan? Do the plans indicate the
type(s) of new finishes to be applied to room surfaces?

As applicable for the overall application proposed,
reviewers will evaluate the following additional items while determining
scientific and technical merit, and in providing an overall impact score, but
will not give separate scores for these items.

Network Organization and Management
Plan (overall application only)

Are the plans for augmenting and strengthening the
state's biomedical research capacity appropriate? Will a scientific thematic
focus be established and maintained? Are the nature, scope, and effectiveness
of the plans for coordination and cooperation among institutions appropriate
and will they contribute to the establishment/continuation of the network?

Does the application describe the nature, scope, and
effectiveness of the plans for coordination and cooperation among research
project investigators?

Is the level of institutional commitment sufficient
to assure that the resources and facilities to sustain the INBRE are present,
including, but not restricted to, existing relevant equipment, animal, and/or
computer resources, and departmental or inter-departmental cooperation?

Are the plans to develop undergraduate and graduate
educational opportunities, ranging from formal programs to courses and
seminars, visiting scientist programs and other similar activities appropriate?

Does the applicant include the plans to establish a
formalized agreement (MOU) among institutions that are to constitute the
scientific network? Does the MOU describe the recourse available to arbitrate
differences in the event that disputes arise? Are issues such as tenure,
promotion, release-time, and other personnel matters pertaining to the success
of the INBRE addressed?

Will the INBRE Award contribute to salaries and
startup funds for promising investigators? Are there other sources of support
for salaries and startup funds?

Does the applicant describe plans to reach
institutions and programs outside the scientific network? Are plans for
networking, sharing of resources and cross-collaborations with COBREs, other
INBREs, and other NIH-supported Centers, if proposed, appropriate?

Are the plans to encourage basic, clinical and /or
translational research across the network adequate?

Protections
for Human Subjects

For research that involves human
subjects but does not involve one of the six categories of research that are
exempt under 45 CFR Part 46, the committee will evaluate the justification for
involvement of human subjects and the proposed protections from research risk
relating to their participation according to the following five review
criteria: 1) risk to subjects, 2) adequacy of protection against risks, 3)
potential benefits to the subjects and others, 4) importance of the knowledge
to be gained, and 5) data and safety monitoring for clinical trials.

For research that involves human
subjects and meets the criteria for one or more of the six categories of
research that are exempt under 45 CFR Part 46, the committee will evaluate: 1)
the justification for the exemption, 2) human subjects involvement and
characteristics, and 3) sources of materials. For additional information on
review of the Human Subjects section, please refer to the Guidelines
for the Review of Human Subjects.

Inclusion
of Women, Minorities, and Children

When the proposed project involves
human subjects and/or NIH-defined clinical research, the committee will
evaluate the proposed plans for the inclusion (or exclusion) of individuals on
the basis of sex/gender, race, and ethnicity, as well as the inclusion (or
exclusion) of children to determine if it is justified in terms of the
scientific goals and research strategy proposed. For additional information on
review of the Inclusion section, please refer to the Guidelines
for the Review of Inclusion in Clinical Research.

Vertebrate
Animals

The committee will evaluate the
involvement of live vertebrate animals as part of the scientific assessment
according to the following criteria: (1) description of proposed procedures
involving animals, including species, strains, ages, sex, and total number to
be used; (2) justifications for the use of animals versus alternative models
and for the appropriateness of the species proposed; (3) interventions to
minimize discomfort, distress, pain and injury; and (4) justification for euthanasia
method if NOT consistent with the AVMA Guidelines for the Euthanasia of
Animals. Reviewers will assess the use of chimpanzees as they would any other
application proposing the use of vertebrate animals. For additional information
on review of the Vertebrate Animals section, please refer to the Worksheet
for Review of the Vertebrate Animal Section.

Biohazards

Reviewers will assess whether
materials or procedures proposed are potentially hazardous to research
personnel and/or the environment, and if needed, determine whether adequate protection
is proposed.

Resubmissions

For Resubmissions, the committee
will evaluate the application as now presented, taking into consideration the
responses to comments from the previous scientific review group and changes
made to the project.

Renewals

For Renewals, the committee will
consider the progress made in the last funding period.

Program Accomplishments (overall application only)

Has previous support allowed the
network to achieve specific benchmarks, which include developing the research
infrastructure and enhancing the research capacity in the partner institutions,
development of science curriculum at the partner institutions, students,
postdoctoral fellows and faculty participating in biomedical research
activities, publishing data in peer-reviewed journals and impact on the state's
workforce?

Is there evidence that
undergraduate students are pursuing science and health-related careers?

As applicable for the project proposed, reviewers will
consider each of the following items, but will not give scores for these items,
and should not consider them in providing an overall impact score.

Applications
from Foreign Organizations

Not Applicable

Select Agent
Research

Reviewers will assess the
information provided in this section of the application, including 1) the Select
Agent(s) to be used in the proposed research, 2) the registration status of all
entities where Select Agent(s) will be used, 3) the procedures that will be
used to monitor possession use and transfer of Select Agent(s), and 4) plans
for appropriate biosafety, biocontainment, and security of the Select Agent(s).

For projects involving key
biological and/or chemical resources, reviewers will comment on the brief plans
proposed for identifying and ensuring the validity of those resources.

Budget and
Period of Support

Reviewers will consider whether the
budget and the requested period of support are fully justified and reasonable
in relation to the proposed research.

2. Review and Selection
Process

Applications will be evaluated for scientific and technical
merit by (an) appropriate Scientific Review Group(s), convened by National
Institute of General Medical Sciences (NIGMS) in accordance with NIH peer
review policy and procedures, using the stated review
criteria. Assignment to a Scientific Review Group will be shown in the eRA
Commons.

As part of the scientific peer review, all applications:

Will receive a written critique.

Applications will be assigned on the basis of established
PHS referral guidelines to the appropriate NIH Institute or Center. Applications
will compete for available funds with all other recommended applications submitted
in response to this FOA. Following initial peer review, recommended applications
will receive a second level of review by the NIGMS Advisory Council. The
following will be considered in making funding decisions:

Scientific and technical merit of the proposed project as
determined by scientific peer review.

Availability of funds.

Relevance of the proposed project to program priorities as only
one award will be made per IDeA-eligible state. If there are more than one
applications from a state, preference will be given to the one with currently
existing effective statewide INBRE network.

3. Anticipated Announcement and Award Dates

After the peer review of the application is completed, the
PD/PI will be able to access his or her Summary Statement (written critique)
via the eRA
Commons. Refer to Part 1 for dates for peer review, advisory council
review, and earliest start date.

If the application is under consideration for funding, NIH
will request "just-in-time" information from the applicant as
described in the NIH Grants
Policy Statement.

A formal notification in the form of a Notice of Award (NoA)
will be provided to the applicant organization for successful applications. The
NoA signed by the grants management officer is the authorizing document and
will be sent via email to the grantee’s business official.

Awardees must comply with any funding restrictions described
in Section IV.5. Funding Restrictions. Selection
of an application for award is not an authorization to begin performance. Any
costs incurred before receipt of the NoA are at the recipient's risk. These
costs may be reimbursed only to the extent considered allowable pre-award costs.

Any application awarded in response to this FOA will be
subject to terms and conditions found on the Award
Conditions and Information for NIH Grants website. This includes any
recent legislation and policy applicable to awards that is highlighted on this
website.

Post-Award Program Requirements for Pilot Project
Investigators

It is emphasized that support cannot be provided in
instances where a pilot project investigator's new award overlaps or is
significantly similar to that described in the INBRE program. When submitting a
new research grant application, the INBRE funded investigators should include a
statement acknowledging INBRE program support and a plan for relinquishing that
support if the proposed research overlaps or is similar to the INBRE project.

If the specific aims of the newly funded project are
significantly different from the project described in the INBRE, then that investigator
has an obligation to remain in the program to complete his/her INBRE project.
In this latter case, continued support for personnel (e.g., postdoctoral
associates, graduate students, technicians, etc.) associated with the INBRE
project but also listed on the other award can be provided. However, the
percent efforts of these individuals must be appropriately adjusted.

Investigators who have acquired independent status or
completed a pilot project should not be excluded from network activities. These
investigators should be allowed access to core facilities and should be
encouraged to participate in collaborative research efforts. If appropriate, an
investigator who has acquired independent status may direct an INBRE or COBRE core
facility or serve as an advisor/collaborator.

An investigator who has achieved independent status and no
longer leads a pilot project may be replaced by a new investigator. Replacement
of investigators and new pilot projects may be selected by the PD(s)/PI(s) and
reviewed by the EAC. In some instances, an investigator may be placed on
probation or considered for removal from the INBRE program if a review by the
EAC indicates a failure by the investigator to make significant progress toward
achieving the specific aims of his/her project. Prior approval by the NIGMS is
required for adding or removing investigators. The PD/PI must communicate the
EAC's recommendation to the NIGMS for programmatic and administrative review.

Prior to the commencement of any pilot or research project,
the following documentation must be submitted to NIGMS staff for administrative
review (see Notice NOT-GM-14-111 for details):

Using PHS398 forms and instructions, only the following
sections need to be submitted:

Face page (signed by institutional signing official)

Project Summary (page 2)

Research Strategy section

Research proposal

Rigor and transparency: As appropriate, a description of the
scientific premise for the proposed project, including consideration of the
strengths and weaknesses of published research or preliminary data crucial to
the support of project, and a description of the experimental design and
methods proposed and how the investigator will achieve robust and unbiased
results. If applicable, a brief description of the methods to ensure the
identity and validity of key biological and/or chemical resources used in the
proposed project (see Notice NOT-OD-16-011 for details).

External Advisory Committee approval – communication from the EAC
chair (at a minimum) indicating that the EAC concurs with supporting the pilot
project.

If proposed study involves human subjects, following documents
must be submitted to NIH:

Written protocol addressing the risks and protections for human
subjects, in accordance with NIH’s Instructions for Preparing the Human
Subjects Section of the Research Plan.

Recipients of federal financial
assistance (FFA) from HHS must administer their programs in compliance with
federal civil rights law. This means that recipients of HHS funds must ensure
equal access to their programs without regard to a person’s race, color,
national origin, disability, age and, in some circumstances, sex and religion.
This includes ensuring your programs are accessible to persons with limited
English proficiency. HHS recognizes that research projects are often limited
in scope for many reasons that are nondiscriminatory, such as the principal
investigator’s scientific interest, funding limitations, recruitment
requirements, and other considerations. Thus, criteria in research protocols that
target or exclude certain populations are warranted where nondiscriminatory
justifications establish that such criteria are appropriate with respect to the
health or safety of the subjects, the scientific study design, or the purpose
of the research.

For additional guidance regarding how the provisions apply
to NIH grant programs, please contact the Scientific/Research Contact that is
identified in Section VII under Agency Contacts of this FOA. HHS provides
general guidance to recipients of FFA on meeting their legal obligation to take
reasonable steps to provide meaningful access to their programs by persons with
limited English proficiency. Please see http://www.hhs.gov/ocr/civilrights/resources/laws/revisedlep.html.
The HHS Office for Civil Rights also provides guidance on complying with civil
rights laws enforced by HHS. Please see http://www.hhs.gov/ocr/civilrights/understanding/section1557/index.html;
and http://www.hhs.gov/ocr/civilrights/understanding/index.html.
Recipients of FFA also have specific legal obligations for serving qualified
individuals with disabilities. Please see http://www.hhs.gov/ocr/civilrights/understanding/disability/index.html.
Please contact the HHS Office for Civil Rights for more information about
obligations and prohibitions under federal civil rights laws at http://www.hhs.gov/ocr/office/about/rgn-hqaddresses.html or call 1-800-368-1019 or TDD 1-800-537-7697. Also note it is an HHS
Departmental goal to ensure access to quality, culturally competent care,
including long-term services and supports, for vulnerable populations. For
further guidance on providing culturally and linguistically appropriate
services, recipients should review the National Standards for Culturally and
Linguistically Appropriate Services in Health and Health Care at http://minorityhealth.hhs.gov/omh/browse.aspx?lvl=2&lvlid=53.

In accordance with the statutory provisions contained in
Section 872 of the Duncan Hunter National Defense Authorization Act of Fiscal
Year 2009 (Public Law 110-417), NIH awards will be subject to the Federal
Awardee Performance and Integrity Information System (FAPIIS) requirements.
FAPIIS requires Federal award making officials to review and consider
information about an applicant in the designated integrity and performance
system (currently FAPIIS) prior to making an award. An applicant, at its
option, may review information in the designated integrity and performance
systems accessible through FAPIIS and comment on any information about itself
that a Federal agency previously entered and is currently in FAPIIS. The
Federal awarding agency will consider any comments by the applicant, in
addition to other information in FAPIIS, in making a judgement about the
applicant’s integrity, business ethics, and record of performance under Federal
awards when completing the review of risk posed by applicants as described in
45 CFR Part 75.205 “Federal awarding agency review of risk posed by
applicants.” This provision will apply to all NIH grants and cooperative
agreements except fellowships.

A summary of the issues discussed at each EAC meeting,
recommendations made, and actions taken must be included in the yearly progress
reports submitted to the NIGMS.

A final progress report, invention
statement, and the expenditure data portion of the Federal Financial Report are
required for closeout of an award, as described in the NIH Grants
Policy Statement.

The Federal Funding Accountability and Transparency Act of
2006 (Transparency Act), includes a requirement for awardees of Federal grants
to report information about first-tier subawards and executive compensation
under Federal assistance awards issued in FY2011 or later. All awardees of
applicable NIH grants and cooperative agreements are required to report to
the Federal Subaward Reporting System (FSRS) available at www.fsrs.gov on all subawards over $25,000. See the NIH Grants
Policy Statement for additional information on this reporting
requirement.

In accordance with the regulatory requirements provided at
45 CFR 75.113 and Appendix XII to 45 CFR Part 75, recipients that have
currently active Federal grants, cooperative agreements, and procurement
contracts from all Federal awarding agencies with a cumulative total value
greater than $10,000,000 for any period of time during the period of
performance of a Federal award, must report and maintain the currency of
information reported in the System for Award Management (SAM) about civil,
criminal, and administrative proceedings in connection with the award or
performance of a Federal award that reached final disposition within the most
recent five-year period. The recipient must also make semiannual
disclosures regarding such proceedings. Proceedings information will be
made publicly available in the designated integrity and performance system
(currently FAPIIS). This is a statutory requirement under section 872 of
Public Law 110-417, as amended (41 U.S.C. 2313). As required by section 3010
of Public Law 111-212, all information posted in the designated integrity and
performance system on or after April 15, 2011, except past performance reviews
required for Federal procurement contracts, will be publicly available. Full
reporting requirements and procedures are found in Appendix XII to 45 CFR Part
75 – Award Term and Conditions for Recipient Integrity and Performance Matters.

Section VII. Agency Contacts

We encourage inquiries concerning this funding opportunity
and welcome the opportunity to answer questions from potential applicants.